A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
Phase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
Checked against the public recordLast updated Feb 13, 2026 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Clasp Therapeutics, Inc.
- Interventions being studied
- Drug: CLSP-1025
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * Patients must be at least 18 years of age at the time of signing the informed consent. * Patients must be willing and able to provide written informed consent * Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists * Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test * Patients must be HLA-A\*02:01 positive by central assay * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment * Adequate hematological, renal and hepatic function * Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation Key Exclusion Criteria: * Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation * Patients who have received other p53 R175H-directed therapies * Patients who have not fully recovered from adverse events due to previous anticancer therapies * Patients with active infection requiring systemic antimicrobial therapy * Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission. * Known active central nervous system metastases and/or carcinomatous meningitis
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- HonorHealth Research InstituteScottsdale, Arizona
- The University of Arizona Cancer CenterTucson, Arizona
- USC - Norris Comprehensive Cancer CenterLos Angeles, California
- University of California Davis Comprehensive Cancer CenterSacramento, California
- University of California San FranciscoSan Francisco, California
- University of Miami - Sylvester Comprehensive Cancer CenterMiami, Florida
- The University of Chicago Comprehensive Cancer CenterChicago, Illinois
- University of Kentucky Markey Cancer CenterLexington, Kentucky
- Johns Hopkins - Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
- Hackensack University Medical CenterHackensack, New Jersey
- NYU Langone HealthNew York, New York
- Memorial Sloan Kettering Cancer CenterNew York, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2026. Always confirm current availability with the study team.